FDA.report

Henry Schein

Primary DI
00304040016282
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
1046825
Catalog number
1046825
Device description
Tischler Biopsy Forceps w/Lock
Published
2019-05-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HFBFORCEPS, BIOPSY, GYNECOLOGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
HFBForceps, Biopsy, GynecologicalObstetrics/Gynecology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00304040016282PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00304040016282003040400162823040400162820304040016282

GMDN Terms

TermDefinition
Gynaecological biopsy forceps, reusableA hand-held manual surgical instrument designed to obtain biopsy specimens from gynaecological tumours or other gynaecological tissues for histopathological examination. It typically has a scissors-like design with ring handles and is made of high-grade stainless steel. The distal tip usually consists of two shaped cutting heads with sharp edges, one fitting exactly into the other, which facilitates the cutting of the biopsy. It is available in various sizes. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
012430880
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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