FDA UDI In Commercial Distribution 🇺🇸 United States

Tischler Morgan Biopsy Forceps Without Lock

DI: G25013042010 · Model: 13-042-01 · N S SURGICAL COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
Tischler Morgan Biopsy Forceps Without Lock
Primary DI
G25013042010
Version / Model
13-042-01
Catalog Number
13-042-01
Company Name
N S SURGICAL COMPANY
Labeler DUNS
645681649
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-04-29
Public Version
1
Public Version Date
2023-05-08
Public Version Status
New
Public Device Record Key
f7e966be-fc47-48c7-9dbf-34b4e4fb6356

Device Description

A hand-held manual surgical instrument designed to obtain soft-tissue biopsy specimens from an open surgical wound or from within/near a large natural orifice (e.g., vagina, rectum) for histopathological examination; it is not intended for endoscopic or catheterized access. It is a metallic forceps-like instrument with a distal mechanism designed to bite/punch the biopsy sample and hold it for extraction when the handles are squeezed together. It is not designed for cutting bone (i.e., not a rongeur). This is a reusable device.

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
No
PM Exempt
Yes
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, Ultraviolet Light, Ethylene Oxide

Product Codes

Code Name
HFB Forceps, Biopsy, Gynecological

GMDN Terms

Code Name
11775 Open-surgery biopsy forceps, reusable

Identifiers

Type ID
Primary G25013042010

Device Sizes

Type Value Unit Text
Length 23 Centimeter
Device Size Text, specify 4.5x2.75x16mm Bite