OsteoMed

Primary DI
00845694045070
Brand
OsteoMed
Company
OSTEOMED LLC
Model
220-0772
Catalog number
220-0772
Device description
SmartFlex 5mm Rongeur
Published
2016-07-21
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HAERONGEUR, MANUAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAERongeur, ManualNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845694045070PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845694045070008456940450708456940450700845694045070

GMDN Terms#

Term, Definition table
TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at a controlled room temperature between 15ºC to 30ºC (59ºF to 86ºF).

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)456-7779Customer.Service@osteomed.com

Regulatory Flags#

DUNS number
606417780
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842528129722OsteoMed336-9101336-91012023-10-13
00842528129739OsteoMed336-9102336-91022023-10-13
00842528129746OsteoMed336-9103336-91032023-10-13
00842528129753OsteoMed336-9104336-91042023-10-13
00842528129760OsteoMed336-9105336-91052023-10-13
00842528129777OsteoMed336-9106336-91062023-10-13
00842528129784OsteoMed336-9107336-91072023-10-13
00842528129791OsteoMed336-9108336-91082023-10-13
00842528129807OsteoMed336-9109336-91092023-10-13
00842528129814OsteoMed336-9110336-91102023-10-13
00842528129821OsteoMed336-9111336-91112023-10-13
00842528129838OsteoMed336-9112336-91122023-10-13
00842528129845OsteoMed336-9201336-92012023-10-13
00842528129852OsteoMed336-9202336-92022023-10-13
00842528129869OsteoMed336-9203336-92032023-10-13
00842528129876OsteoMed336-9204336-92042023-10-13
00842528129883OsteoMed336-9205336-92052023-10-13
00842528129890OsteoMed336-9206336-92062023-10-13
00842528129906OsteoMed336-9207336-92072023-10-13
00842528129913OsteoMed336-9208336-92082023-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810220800089Adler Instrument CompanyAdler, Inc.HAE2026-05-26
04057034294543Punch, acc. Kerrison, K-Rex™ 40° upwards 18cm 1mm,w.ejectorGeister Medizintechnik GmbHHAE2026-05-26
04058749092523NAFehling Instruments GmbH & Co. KGHAE2026-03-05
00190776416515MillenniumAvalign Technologies, Inc.HAE2026-02-16
00887482023389SymmetryASPEN SURGICAL PRODUCTS, INC.HAE2026-02-15
00887482023396SymmetryASPEN SURGICAL PRODUCTS, INC.HAE2026-02-15
00887482023402SymmetryASPEN SURGICAL PRODUCTS, INC.HAE2026-02-15
00887482156186SymmetryASPEN SURGICAL PRODUCTS, INC.HAE2026-02-15
00887482156223SymmetryASPEN SURGICAL PRODUCTS, INC.HAE2026-02-15
20887482023376SymmetryASPEN SURGICAL PRODUCTS, INC.HAE2026-02-15
04058749089776NAFehling Instruments GmbH & Co. KGHAE2025-09-01
04046955741212AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741229AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741236AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741243AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741250AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741267AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741274AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741281AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741298AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741304AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741311AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741328AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741335AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741342AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741359AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741366AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741373AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741380AESCULAPAESCULAP, INC.HAE2025-08-17
04046955741397AESCULAPAESCULAP, INC.HAE2025-08-17