FDA.reportPublic FDA data

OSTYCUT®

Primary DI
00801741083754
Brand
OSTYCUT®
Company
Angiomed GmbH & Co. Medizintechnik KG
Model
17860010
Catalog number
17860010
Device description
OSTYCUT® Disposable Bone Biopsy Needles, 14.5g x 50mm
Published
2016-09-06
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAANEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAANeedle, Aspiration And Injection, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10801741083751PackageGS110Not in Commercial Distribution
00801741083754PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174108375110801741083751
00801741083754008017410837548017410837540801741083754

GMDN Terms#

Term, Definition table
TermDefinition
Bone marrow biopsy needle, single-useA sterile, sharp bevel-edged, hollow tubular metal instrument designed to obtain a specimen of bone marrow percutaneously. The device is typically available in a variety of large bores, and is sufficiently robust to penetrate bone (usually the hip bone or posterior iliac crest) with the force of pressure and twisting manually applied to its proximal handgrip. The resultant specimen is typically used for the pathological analysis of the source of blood cellular elements. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length50Millimeter
Needle Gauge14.5Gauge

Contacts#

Phone, Email table
PhoneEmail
+4972194450ute.dreschner@crbard.com

Regulatory Flags#

DUNS number
320047483
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00801741103131Venovo®VENUM10040VENUM100402019-03-18
00801741103148Venovo®VENUM10060VENUM100602019-03-18
00801741103155Venovo®VENUM10080VENUM100802019-03-18
00801741103162Venovo®VENUM10100VENUM101002019-03-18
00801741103179Venovo®VENUM10120VENUM101202019-03-18
00801741103186Venovo®VENUM10140VENUM101402019-03-18
00801741103193Venovo®VENUM10160VENUM101602019-03-18
00801741103209Venovo®VENUL10040VENUL100402019-03-18
00801741103216Venovo®VENUL10060VENUL100602019-03-18
00801741103223Venovo®VENUL10080VENUL100802019-03-18
00801741103230Venovo®VENUL10100VENUL101002019-03-18
00801741103247Venovo®VENUL10120VENUL101202019-03-18
00801741103254Venovo®VENUL10140VENUL101402019-03-18
00801741103261Venovo®VENUL10160VENUL101602019-03-18
00801741103278Venovo®VENUM12040VENUM120402019-03-18
00801741103285Venovo®VENUM12060VENUM120602019-03-18
00801741103292Venovo®VENUM12080VENUM120802019-03-18
00801741103308Venovo®VENUM12100VENUM121002019-03-18
00801741103315Venovo®VENUM12120VENUM121202019-03-18
00801741103322Venovo®VENUM12140VENUM121402019-03-18

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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