FDA.report

Cervical Biopsy Punch

Primary DI
05060411985346
Brand
Cervical Biopsy Punch
Company
DTR MEDICAL LIMITED
Model
1
Catalog number
CBR1041
Device description
Cervical biopsy punch with rotation
Published
2021-11-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
HFBForceps, Biopsy, Gynecological

Product Code Classifications

CodeDeviceSpecialtyClass
HFBForceps, Biopsy, GynecologicalObstetrics/Gynecology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05060411985346PackageGS110In Commercial Distribution
05060411985339PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05060411985346050604119853465060411985346
05060411985339050604119853395060411985339

GMDN Terms

TermDefinition
Open-surgery biopsy forceps, single-useA 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 single-use device.

Device Sizes

TypeValueUnit
Length365Millimeter

Sterilization Methods

Method

Regulatory Flags

DUNS number
424066509
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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05060212055927Zoellner type, 2mm x 85mm, 10 degree shallow distal bend, without suction contro74-2011 2024-10-14
05060212056665Zoellner type, 2mm x 85mm, distal bend acute 30 degree angle, without suction co74-2012 2024-10-14
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05060212057013Zoellner type, 2mm x 85mm, 10 degree shallow distal bend, with suction control h74-2013 2024-10-14

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