- Physicians Office Resource

Skin Stapler STERILE
McKesson - 16-3001

Device Description

A hand-held manual, surgical instrument preloaded with non-bioabsorbable skin staples designed to apply the staples to approximate the free skin edges of an incision or wound. The staples (which may be clip-like) are made of metal [e.g., stainless steel or titanium (Ti)] and intended to be removed once the wound has sufficiently healed. This is a single-use device.

Environmental Conditions

No Data Available

Device Sizes

No Data Available

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: GAG

Device Name: Stapler, Surgical

Device Class: 2

Physical State: A specialized prescription device that delivers compatible staples to internal tissues.

Definition: A surgical stapler for internal use is a specialized prescription device used to deliver compatible staples to internal tissues during surgery for resection, transection, and creating anastomoses.

Submission Type ID: 1

Review Panel: SU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: A specialized prescription device that delivers compatible staples to internal tissues.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Internal tissues.

Regulation Number: 878.4740

Third Party Flag: N

Medical Specialty: HO

Device Identifiers

Device Id: 20612479214785

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10612479214801

Package Quantity: 10

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Box

Device Id: 10612479214801

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

Device Id: 40612479214796

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 20612479214785

Package Quantity: 3

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Case

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