FDA.reportPublic FDA data

Oral Biopsy Forceps Long 180 mm

Primary DI
05060411987418
Brand
Oral Biopsy Forceps Long 180 mm
Company
DTR MEDICAL LIMITED
Model
OBRL1001
Published
2024-10-14
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

Product Codes#

Code, Name table
CodeName
KAEForceps, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAEForceps, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060411987418PackageGS110In Commercial Distribution
05060411987401PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060411987418050604119874185060411987418
05060411987401050604119874015060411987401

GMDN Terms#

Term, Definition table
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.

Sterilization Methods#

Method table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060212050038Aspirating Needle 335 x 3.5mm (18g) with LuerASN50182026-06-11
05060212051066Oral Biopsy Forceps 90mmOBF1001-S2026-06-11
05060212051073Oral Biopsy Forceps Long 120mmOBFL1001-S2026-06-11
05060411981119Pierse Hoskins Forceps 85mm, 0.2mm Notched TipsPHF10852026-06-11
05060411987579Oral Rotating Biopsy Punch 120 mmOBRSAMPLE-32026-06-12
05060411987586Oral Biopsy Punch Long 180 mmOBRLSAMPLE-32026-06-12
05060212050021Aspirating Needle 335 x 3.5mm (18g) with LuerASN20182026-06-10
05060411983007Capsulorhexis Forceps, Utrata Tips, 12mm Curved Shafts, Round HandlesCXF20012026-06-10
05060411987388Oral Rotating Biopsy Forceps 120 mmOBR10012024-10-14
05060411987401Oral Biopsy Forceps Long 180 mmOBRL10012024-10-14
05060411982963Birks Tying Forceps 110mm, 5mm Platform with 0.3mm TipsBTF21152026-06-10
05060212050687Bruenings Tongue Depressor, 190mmBRU20012026-06-10
05060212051042Crocodile Scissors Straight, stainless steelCSS1001-S2026-06-10
05060212051059Crocodile Scissors Curved, stainless steelCSC1001-S2026-06-10
05060212051103Crile Artery Forceps, 145mm StraightCFS2001-D2026-06-10
05060212051110Crile Artery Forceps, 145mm Curved on FlatCFC2001-D2026-06-10
05060212051196Adson Non-Toothed Forceps 120mmADS5001-S2026-06-10
05060212051202Adson Toothed Forceps 120mmATS5001-S2026-06-10
05060212051264College Dental Forceps 160mmCDF20012026-06-10
05060212051721Clamp Cover Red (Small) 50mmCCR20312026-06-10

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Primary DI, Brand, Company table
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B382SD9196141000Surgical DirectSurgical Direct, Inc.KAE2026-07-29
B382SD9196141010Surgical DirectSurgical Direct, Inc.KAE2026-07-29
B382SD9202421000Surgical DirectSurgical Direct, Inc.KAE2026-07-29
B382SD9202421010Surgical DirectSurgical Direct, Inc.KAE2026-07-29
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