FDA.report

Adler Instrument Company

Primary DI
00810123200078
Brand
Adler Instrument Company
Company
Adler, Inc.
Model
32-5138
Device description
BONE REDUCTION FCPS CVD 7-3/4
Published
2023-03-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GENForceps, General & Plastic Surgery

Product Code Classifications

CodeDeviceSpecialtyClass
GENForceps, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810123200078PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810123200078008101232000788101232000780810123200078

GMDN Terms

TermDefinition
Bone approximation clampA hand-held manual surgical instrument designed to grip and hold a bone or, being used in pairs one on either side of the fracture, to approximate the proximal and distal segment of a fractured bone during orthopaedic surgery. It is typically made of high-grade stainless steel and is designed with a double hooked, blade-like jaw at the distal end (this hooks over the upper edge of the bone) whilst an adjustable single hook is tightened against the lower edge of the bone through a screw mechanism. A traction bar may be employed to bridge the two bone clamps and using its screw mechanism, the fracture is drawn together. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
8772416747orders@theadlerinstruments.com

Regulatory Flags

DUNS number
830141235
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
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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00810220800010Adler Instrument Company38-52192026-03-17
00810220800027Adler Instrument Company30-02182026-03-17
00810220800034Adler Instrument Company34-00982026-03-17
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00810123209866Adler Instrument Company32-55032026-03-03
00810123209873Adler Instrument Company32-55052026-03-03
00810123209880Adler Instrument Company32-55062026-03-03
00810123209897Adler Instrument Company32-55072026-03-03
00810123209903Adler Instrument Company32-55082026-03-03
00810123209910Adler Instrument Company32-55092026-03-03
00810123209927Adler Instrument Company70-04552026-03-03
00810123209934Adler Instrument CompanyAD11-10032026-03-03
00810123209941Adler Instrument CompanyAD24-60432026-03-03
00810123209958Adler Instrument Company200-2832026-03-03
00810123209965Adler Instrument Company30-03152026-03-03
00810123209972Adler Instrument CompanyAD21-23052026-03-03

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