FDA.reportPublic FDA data

NA

Primary DI
04042409193170
Brand
NA
Company
aap Implantate AG
Model
IS 2310-32
Device description
Countersink cannulated CS 6.5/7.5, Jacobs chuck
Published
2018-02-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HWWCOUNTERSINK

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWWCountersinkOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04042409193170PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04042409193170040424091931704042409193170

GMDN Terms#

Term, Definition table
TermDefinition
Surgical countersink, reusableA rotary surgical instrument designed to enlarge the diameter of the proximal portion of a hole drilled in bone. It is a shaft of metal with a cutting head, available in various configurations, that is rotated at low speeds typically by a drilling system. The device is typically used to recess the head of a screw/bolt within bone (enable it to lie flush with or below the bone surface) or to help accommodate the implantation of a device in bone. 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
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
04042409363337NAIP 2506-002018-02-28
04042409387555LOQTEQ®IU 8166-042018-02-28
04042409202711LOQTEQ®PG 3555-04-2PG 3555-04-22016-08-18
04042409202728LOQTEQ®PG 3555-05-2PG 3555-05-22016-08-18
04042409202735LOQTEQ®PG 3555-06-2PG 3555-06-22016-08-18
04042409202742LOQTEQ®PG 3555-07-2PG 3555-07-22016-08-18
04042409202766LOQTEQ®PG 3555-08-2PG 3555-08-22016-08-18
04042409202773LOQTEQ®PG 3555-09-2PG 3555-09-22016-08-18
04042409202797LOQTEQ®PG 3555-10-2PG 3555-10-22016-08-18
04042409202803LOQTEQ®PG 3555-11-2PG 3555-11-22016-08-18
04042409202810LOQTEQ®PG 3555-12-2PG 3555-12-22016-08-18
04042409202827LOQTEQ®PG 3555-14-2PG 3555-14-22016-08-18
04042409202834LOQTEQ®PG 3555-16-2PG 3555-16-22016-08-18
04042409202841LOQTEQ®PG 3555-18-2PG 3555-18-22016-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841731146854TITANEX VILEX LLCHWW2026-05-15
00841731146878TITANEX VILEX LLCHWW2026-05-15
00841731146892TITANEX VILEX LLCHWW2026-05-15
00841731146915TITANEX VILEX LLCHWW2026-05-15
00841731146939TITANEX VILEX LLCHWW2026-05-15
03700569679170Newclip InstrumentsNEWCLIP TECHNICSHWW2026-05-05
03700569679187Newclip InstrumentsNEWCLIP TECHNICSHWW2026-05-05
00810211043945Ultra Compression Screw SystemPace Surgical, Inc.HWW2026-04-27
00810211043952Ultra Compression Screw SystemPace Surgical, Inc.HWW2026-04-27
00810211043969Ultra Compression Screw SystemPace Surgical, Inc.HWW2026-04-27
00810211043976Ultra Compression Screw SystemPace Surgical, Inc.HWW2026-04-27
00810211043983Ultra Compression Screw SystemPace Surgical, Inc.HWW2026-04-27
00810211043990Ultra Compression Screw SystemPace Surgical, Inc.HWW2026-04-27
00810211044003Ultra Compression Screw SystemPace Surgical, Inc.HWW2026-04-27
00810211044010Ultra Compression Screw SystemPace Surgical, Inc.HWW2026-04-27
08437019739430WasherCap™ Countersink 11 mmABANZA TECNOMED SL.HWW2026-03-30
00810111225281Instrument TrayTreace Medical Concepts, Inc.HWW2026-03-30
05055662971576ORTHO SOLUTIONS SUCCESSION AFN SYSTEMORTHO SOLUTIONS HOLDINGS LIMITEDHWW2026-03-04
00841731135308Redemption VILEX LLCHWW2026-01-12
00840118126250Active CompressionFLOWER ORTHOPEDICS CORPORATIONHWW2025-11-21
00840118126267Active CompressionFLOWER ORTHOPEDICS CORPORATIONHWW2025-11-21
00889795141330Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.HWW2025-11-19
00194613014766MSI Precision Specialty InstrumentsMed Saver, Inc.HWW2025-08-01
00885556896464TRIGEN MAXSmith & Nephew, Inc.HWW2025-05-07
04042409452741NAaap Implantate AGHWW2025-02-26
04042409452789NAaap Implantate AGHWW2025-02-26
04042409452826NAaap Implantate AGHWW2025-02-26
04042409452864NAaap Implantate AGHWW2025-02-26
10888277373754MEDLINEMEDLINE INDUSTRIES, INC.HWW2025-02-21
10888277379152MEDLINEMEDLINE INDUSTRIES, INC.HWW2025-02-21