FDA.reportPublic FDA data

ATHLET

Primary DI
04047844044643
Brand
ATHLET
Company
SIGNUS Medizintechnik GmbH
Model
Height indicator
Catalog number
AT0002
Device description
An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.
Published
2022-06-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTSKnife, Orthopedic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTSKnife, OrthopedicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04047844044643PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04047844044643040478440446434047844044643

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+49602391660info@signus.com

Regulatory Flags#

DUNS number
344203948
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
04047844129241DIPLOMATThreaded awl cannulated, obturatorAC00882026-05-20
04047844129258DIPLOMATThreaded awl cannulated, obturatorAC00892026-05-20
04047844102596COSYCross connectorCA0155-38048/S2023-03-21
04047844102602COSYCross connectorCA0155-44052/S2023-03-21
04047844098479COSYRetaining nut tulips cross connectorCA0160-002002023-03-15
04047844127063COSYTray, lidCB03AY-LID-12026-04-22
04047844098707COSYOcciput plateCA0005-320562023-03-15
04047844116432COSYObturatorwireCB0101-32023-03-15
04047844116449COSYGuide wire, round/roundCB01442023-03-15
04047844129272INSTRUMENTTray, instrumentsP009AY2026-02-11
04047844129289INSTRUMENTTray, insert, instrumentsP009AZ2026-02-11
04047844129296COSYTray, implantsCA01AY2026-02-11
04047844129302COSYTray, insert, implantsCA01AZ2026-02-11
04047844129319COSYTray, implantsCA02AY2026-02-11
04047844129326COSYRack, screwsCA1235AZ2026-02-11
04047844129333COSYRack, screwsCA1240AZ2026-02-11
04047844129340COSYRack, screwsCA1245AZ2026-02-11
04047844129357COSYRack, shank screwsCA1735AZ2026-02-11
04047844129364COSYRack, shank screwsCA1740AZ2026-02-11
04047844129371COSYRack, screws angledCA3235AZ2026-02-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00192896122796McIlwraith Bistouri KnifeSONTEC INSTRUMENTS, INC.HTS2026-03-10
00853508002645BE-ST Sheathed Bayonet Surgical Knife Lacey Manufacturing Company, LLCHTS2026-03-02
00853508002539BE-ST Sheathed Bayonet Surgical Knife Lacey Manufacturing Company, LLCHTS2026-02-16
00840967154527SigmaALPHATEC SPINE, INC.HTS2025-07-23
00192896121560Arthroscopic Bayonet KnifeSONTEC INSTRUMENTS, INC.HTS2025-05-14
10888277392687MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-04-17
00853508002621BESTLacey Manufacturing Company, LLCHTS2025-03-25
10080196392582MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-22
10080196392636MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10080196392643MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10080196392667MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392564MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392571MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392588MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392595MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392601MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392618MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392625MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392632MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392649MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392656MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392663MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392670MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392694MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392700MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392717MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392724MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10080196392575MEDLINE RENEWALMEDLINE INDUSTRIES, INC.HTS2025-02-11
00843575121219b-ONE Hip SpecialtyB-ONE ORTHO, CORP.HTS2025-01-22
08800147701097Target Endoscopic InstrumentSOLENDOS Inc.HTS2024-12-09