FDA.report

N/A

Primary DI
B582804470
Brand
N/A
Company
GEORGE TIEMANN & CO.
Model
80447
Catalog number
80447
Device description
FORCEPS, RONGEUR, SURGICAL
Published
2020-09-24
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

Contact Domains

Product Codes

CodeName
EMHFORCEPS, RONGEUR, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
EMHForceps, Rongeur, SurgicalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B582804470PrimaryHIBCC0

GMDN Terms

TermDefinition
Open-surgery biopsy forceps, reusableA 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.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(631)273-0005stephen@georgetiemann.com

Regulatory Flags

DUNS number
107043630
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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B582070609STFRA0N/A070609STFRA070609STFRA2020-09-24
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B58208009930N/A8009938009932020-09-24
B58208009940N/A8009948009942020-09-24
B58208009950N/A8009958009952020-09-24

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