BEUDAMED

FDA UDI Not in Commercial Distribution 🇺🇸 United States

Symmetry Debakey

DI: 00887482149478 · Model: 95-1091 · ASPEN SURGICAL PRODUCTS, INC.

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Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

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Basic Information

Brand Name: Symmetry Debakey
Primary DI: 00887482149478
Version / Model: 95-1091
Catalog Number: 95-1091
Company Name: ASPEN SURGICAL PRODUCTS, INC.
Labeler DUNS: 027680821
Distribution Status: Not in Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2016-09-27
Public Version: 7
Public Version Date: 2025-10-29
Public Version Status: Update
Public Device Record Key: 7bff6ad6-a569-484a-b0d8-16565649c9b3
Distribution End Date: 2022-02-28

Device Description

Grasper 5mm, 33cm, Non Locking

Device Characteristics

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

Sterilization

Is Sterile: No
Sterilization Prior Use: Yes
Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
11791	Dressing/utility forceps, scissors-like, reusable	A hand-held manual instrument designed primarily for non-dedicated grasping of devices, sponges and/or dressings during a procedure; it is neither intended for tissue manipulation nor endoscopic use. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00887482149478	GS1

Customer Contacts

Phone: +1 888-364-7004
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K946263	000