FDA.reportPublic FDA data

CLOVER STAPLE 3 LEG 10 X 8 X 12.5

Primary DI
00810012481625
Brand
CLOVER STAPLE 3 LEG 10 X 8 X 12.5
Company
BIOPRO, INC.
Model
18263
Published
2019-06-04
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
JDRStaple, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDRStaple, Fixation, BoneOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810012481625PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810012481625008100124816258100124816250810012481625

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone staple, non-adjustable, sterileA sterile, non-bioabsorbable, implantable device designed to be inserted into fractured bone to achieve fixation and repair; the device may also be used to attach/secure structures (e.g., ligaments/tendons) to bone, or to reduce/cease bone growth in skeletal deformities (e.g., by being implanted across epiphysial cartilage). It is typically a curved or U-shaped device made of metal alloy material, and is not adjustable after it has been applied. Disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
618749857
Device count
1
DM exempt
false
Premarket exempt
false
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M209232580Hintermann Compressor232582026-05-22
M209232590Hintermann Distractor232592026-05-22
M20923217MTP Targeting Guide Assembly232172025-11-28
M20923227Modular Thumb Rasp Serrated 7.5MM232272025-11-28
M20923228Modular Thumb Rasp Serrated 8.5MM232282025-11-28
M20923229Modular Thumb Rasp Serrated 10.0MM232292025-11-28
M20923230Modular Thumb Rasp Serrated 11.5MM232302025-11-28
M209177990THUMB MOD HEAD TITANIUM 13MM+2177992024-06-30
M209178000THUMB MOD HEAD TITANIIUM 12MM177802024-06-30
M209178010THUMB MOD HEAD TITANIUM 12MM+2178012024-06-30
M209178060THUMB MOD HEAD TITANIUM 14MM178062024-06-30
M209178070THUMB MOD HEAD TITANIUM 14MM+2178072024-06-30
M209178080THUMB MOD HEAD TITANIUM 15MM178082024-06-30
M209178090THUMB MOD HEAD TITANIUM 15MM+2178092024-06-30
M209177980THUMB MOD HEAD TITANIUM 13MM177982024-05-30
M209230790MTP FUSION PLATE 5 DEGREE, LEFT230792024-03-26
M209230800MTP FUSION PLATE 5 DEGREE, RIGHT230802024-03-26
M209230810MTP FUSION PLATE 0 DEGREE, LEFT230812024-03-26
M209230820MTP FUSION PLATE 0 DEGREE, RIGHT230822024-03-26
M209230830MTP FUSION PLATE, NARROW 10 DEGREE, LEFT230832024-03-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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05060267134530Fastlok 6mm x 23mmXIROS LTDJDR2026-02-16
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10193489020915MEDLINEMEDLINE INDUSTRIES, INC.JDR2026-02-10
10193489020946MEDLINEMEDLINE INDUSTRIES, INC.JDR2026-02-10
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00810135964180VertexNVISION BIOMEDICAL TECHNOLOGIES, INC.JDR2025-12-17
00810111224918TMC FastPitch ScrewsTreace Medical Concepts, Inc.JDR2025-12-12
00810111225175TMC SpeedTMTTreace Medical Concepts, Inc.JDR2025-12-12
00810111225199TMC SpeedTMTTreace Medical Concepts, Inc.JDR2025-12-12
00810111225373TMC SpeedTMTTreace Medical Concepts, Inc.JDR2025-12-12
00810111224857TMC SpeedMTPTreace Medical Concepts, Inc.JDR2025-11-14
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00860005968831RELJA Innovations Nitinol Staple Kit 18x18Relja Innovations LLCJDR2025-09-19
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