Proximate

Basic Information

• Brand Name: Proximate
• Primary DI: 10705036013013
• Version / Model: PRR35
• Catalog Number: PRR35
• Company Name: ETHICON ENDO-SURGERY, LLC
• Labeler DUNS: 044606982
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-15
• Public Version: 4
• Public Version Date: 2021-03-10
• Public Version Status: Update
• Public Device Record Key: a0441138-96fd-4a33-b03b-c676f2c1b2d3

Device Description

Proximate RH Rotating Head skin Staplers (35 Regular) Contains 35 Stainless Steel Staples

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GDT	STAPLE, REMOVABLE (SKIN)	General, Plastic Surgery	878.4760	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35884	Skin stapler/staple, non-bioabsorbable	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	40705036013014	GS1	CASE	54	In Commercial Distribution
Primary	10705036013013	GS1
Package	30705036013017	GS1	CASE	72	In Commercial Distribution
Package	20705036013010	GS1	BOX	6	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]