FDA.report

NA

Primary DI
07611819282995
Brand
NA
Company
Synthes GmbH
Model
398.752
Catalog number
398752
Device description
HOHMANN-STYLE ARM 183MM
Published
2016-12-31
Public version status
Update
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
HTDFORCEPS

Product Code Classifications

CodeDeviceSpecialtyClass
HTDForcepsGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07611819282995Direct MarkingGS10
10886982201560PrimaryGS10
H6793987520SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07611819282995076118192829957611819282995
1088698220156010886982201560

GMDN Terms

TermDefinition
Temporal bone holderA surgical device used to hold a piece of bone in a clamped position outside of the surgical field while the surgeon and/or other helping assistants work on it. It is typically used to reshape bone or for creating grafting material. This device will typically have a sturdy foot, a clamp to hold the bone, and an integral dish-like bowl to catch the bone fragments/cuttings. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags

DUNS number
486711679
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

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