FDA.report

7" ROUND HANDLE TISSUE FORCEPS, STRAIGHT, WITH TYING PLATFORM, DIAMOND DUSTED

Primary DI
D9282201250
Brand
7" ROUND HANDLE TISSUE FORCEPS, STRAIGHT, WITH TYING PLATFORM, DIAMOND DUSTED
Company
W.H. Holden, Inc.
Model
22-0125
Published
2023-12-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EFLFORCEPS, DRESSING, DENTAL

Product Code Classifications

CodeDeviceSpecialtyClass
EFLForceps, Dressing, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D9282201250PrimaryHIBCC0

GMDN Terms

TermDefinition
Surgical soft-tissue manipulation forceps, tweezers-like, reusableA hand-held, manual, open-surgery instrument designed to facilitate grasping and manipulation of soft-tissues. It has a tweezers-like design (may be a micro/fine instrument) with variously designed tips at the working end, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles). It is made of high-grade stainless steel, available in various sizes, and may have carbide inserts at the working end. It is not an electrosurgical device and not dedicated to ophthalmic surgery. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
183854322
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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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