OsteoMed

Primary DI
00845694044998
Brand
OsteoMed
Company
OSTEOMED LLC
Model
218-3060-SP
Catalog number
218-3060-SP
Device description
SmartFlex Spring - Small - 6N
Published
2015-04-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PBJCranial Distraction System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PBJCranial Distraction SystemNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845694044998PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845694044998008456940449988456940449980845694044998

GMDN Terms#

Term, Definition table
TermDefinition
Cranioplasty plate, alterableAn implantable shield designed to repair larger skull defects that is preformed before surgery and typically made of sheets of material (e.g., tantalum) that can be reshaped at the time of surgery without changing the physical or chemical properties of the material. The device is generally preformed with a central convex curvature matching the curvature of the forehead, side, or rear areas of the human adult skull; it is usually fixed to the intact cranial bones using screws and/or other fasteners. The device is used to repair defects due to injury, surgical intervention for tumour removal, congenital anomaly, or disease.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00888118149367DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.PBJ2025-09-24
00888118136589DISTRACTION, INTERNALKLS-Martin L.P.PBJ2023-12-25
00888118136596DISTRACTION, INTERNALKLS-Martin L.P.PBJ2023-12-25
00888118136626DISTRACTION, INTERNALKLS-Martin L.P.PBJ2023-12-25
00888118136633DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.PBJ2023-12-25
00888118136640DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.PBJ2023-12-25
00888118136657DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.PBJ2023-12-25
H98004315852010NASYNTHES (U.S.A.) LPPBJ2019-12-12
H98004315784010NASYNTHES (U.S.A.) LPPBJ2019-12-12
H98004315788010NASYNTHES (U.S.A.) LPPBJ2019-12-12
H98004315792010NASYNTHES (U.S.A.) LPPBJ2019-12-12
H98004315806010NASYNTHES (U.S.A.) LPPBJ2019-12-12
H98004315824050NASYNTHES (U.S.A.) LPPBJ2019-12-12
H98004315832050NASYNTHES (U.S.A.) LPPBJ2019-12-12
H98004315786050NASYNTHES (U.S.A.) LPPBJ2019-12-12
H98004315788050NASYNTHES (U.S.A.) LPPBJ2019-12-12
H98004315790050NASYNTHES (U.S.A.) LPPBJ2019-12-12
H98004315804050NASYNTHES (U.S.A.) LPPBJ2019-12-12
H98004315846050NASYNTHES (U.S.A.) LPPBJ2019-12-12
H98004315850050NASYNTHES (U.S.A.) LPPBJ2019-12-12
H98004315808050NASYNTHES (U.S.A.) LPPBJ2019-12-12
H98004315810050NASYNTHES (U.S.A.) LPPBJ2019-12-12
00842528123300OsteoMedOSTEOMED LLCPBJ2019-11-08
00842528123317OsteoMedOSTEOMED LLCPBJ2019-11-08
00888118114310DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.PBJ2018-01-12
00888118114464DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.PBJ2018-01-12
00888118114471DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.PBJ2018-01-12
00888118114488DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.PBJ2018-01-12
00888118114495DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.PBJ2018-01-12
00888118114501DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.PBJ2018-01-12