FDA.reportPublic FDA data

NA

Primary DI
04042409402012
Brand
NA
Company
aap Implantate AG
Model
IU 2503-20
Device description
Distractor for K-wires ø1.6
Published
2018-02-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HTDFORCEPS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTDForcepsGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04042409402012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04042409402012040424094020124042409402012

GMDN Terms#

Term, Definition table
TermDefinition
Bone distraction forcepsA hand-held, manual, open-surgery instrument with sturdy handles and blade-like jaws designed to distract (force apart) two bone surfaces to enable a surgical procedure, e.g., two vertebrae during a spinal surgical intervention. It has a scissors-like lever action with straight or curved handles and is typically made of high-grade stainless steel. It is available in various sizes with the distraction blades at the working end which are activated through a single or double-jointed pivot that transfers the necessary force to create distraction; the blades are typically short and slender to fit between bone segments or pre-implanted pedicle screws. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
328420633
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04042409200021NASC 4030-46-2SC 4030-46-22016-08-18
04042409200038NASC 4030-48-2SC 4030-48-22016-08-18
04042409200045NASC 4030-50-2SC 4030-50-22016-08-18
04042409200076NASC 4050-10-2SC 4050-10-22016-08-18
04042409200083NASC 4050-12-2SC 4050-12-22016-08-18
04042409200090NASC 4050-14-2SC 4050-14-22016-08-18
04042409200106NASC 4050-16-2SC 4050-16-22016-08-18
04042409200120NASC 4050-18-2SC 4050-18-22016-08-18
04042409200151NASC 4050-20-2SC 4050-20-22016-08-18
04042409200168NASC 4050-22-2SC 4050-22-22016-08-18
04042409236990NASC 4030-46SC 4030-462016-08-18
04042409237003NASC 4030-48SC 4030-482016-08-18
04042409237010NASC 4030-50SC 4030-502016-08-18
04042409237027NASC 4030-55SC 4030-552016-08-18
04042409035807NAIP 0104-002018-02-28
04042409035845NAIP 0104-012018-02-28
04042409002939NAIP 8403-002018-02-28
04042409036170NAIP 2505-002018-02-28
04042409207273NAIP 8405-002018-02-28
04042409228995NAIP 8405-502018-02-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776426583MillenniumAvalign Technologies, Inc.HTD2026-08-19
00190776426590MillenniumAvalign Technologies, Inc.HTD2026-08-19
00190776426712MillenniumAvalign Technologies, Inc.HTD2026-08-19
04054462911905evonosevonos GmbH & Co. KGHTD2026-08-19
04054462912926evonosevonos GmbH & Co. KGHTD2026-08-19
04054462913336evonosevonos GmbH & Co. KGHTD2026-08-19
04054462913343evonosevonos GmbH & Co. KGHTD2026-08-19
04054462913398evonosevonos GmbH & Co. KGHTD2026-08-19
04054462913404evonosevonos GmbH & Co. KGHTD2026-08-19
04054462913411evonosevonos GmbH & Co. KGHTD2026-08-19
04054462913428evonosevonos GmbH & Co. KGHTD2026-08-19
04054462913442evonosevonos GmbH & Co. KGHTD2026-08-19
00190776417048MillenniumAvalign Technologies, Inc.HTD2026-08-18
04054462901814evonosevonos GmbH & Co. KGHTD2026-08-18
04054462901838evonosevonos GmbH & Co. KGHTD2026-08-18
04054462901845evonosevonos GmbH & Co. KGHTD2026-08-18
04054462903429evonosevonos GmbH & Co. KGHTD2026-08-18
04054462903436evonosevonos GmbH & Co. KGHTD2026-08-18
04054462903474evonosevonos GmbH & Co. KGHTD2026-08-18
04054462903481evonosevonos GmbH & Co. KGHTD2026-08-18
04054462903498evonosevonos GmbH & Co. KGHTD2026-08-18
04054462903511evonosevonos GmbH & Co. KGHTD2026-08-18
04054462903528evonosevonos GmbH & Co. KGHTD2026-08-18
04054462903535evonosevonos GmbH & Co. KGHTD2026-08-18
04054462903542evonosevonos GmbH & Co. KGHTD2026-08-18
04054462903559evonosevonos GmbH & Co. KGHTD2026-08-18
04054462903566evonosevonos GmbH & Co. KGHTD2026-08-18
04054462903580evonosevonos GmbH & Co. KGHTD2026-08-18
04054462903610evonosevonos GmbH & Co. KGHTD2026-08-18
04054462903627evonosevonos GmbH & Co. KGHTD2026-08-18