FDA.reportPublic FDA data

Reicodent

Primary DI
04061644045594
Brand
Reicodent
Company
devemed GmbH
Model
02-1020-1
Device description
"Gauze Packer ""Luniatschek"" # 13.0 mmOctagonal handle, solid, serrated"
Published
2020-05-04
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
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04061644045594PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04061644045594040616440455944061644045594

GMDN Terms#

Term, Definition table
TermDefinition
Gauze packerA hand-held, surgical instrument used for introducing and packing gauze or dressings into body cavities. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+4974679491990info@devemed.de

Regulatory Flags#

DUNS number
506826739
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04061644037469Reicodent02-2599-00 C2020-05-04
04061644041169Reicodent02-1082020-05-04
04061644048601Reicodent02-25942020-05-04
04061644048625Reicodent02-2595-1 G2020-05-04
04061644048632Reicodent02-2595-1 S2020-05-04
04061644048649Reicodent02-2595-1 ST2020-05-04
04061644048663Reicodent02-2595-2 G2020-05-04
04061644048670Reicodent02-2595-2 S2020-05-04
04061644048731Reicodent02-2595-A2020-05-04
04061644048748Reicodent02-2595-B2020-05-04
04061644048755Reicodent02-2595-C2020-05-04
04061644048854Reicodent02-26932020-05-04
04061644048908Reicodent02-27072020-05-04
04061644048915Reicodent02-27082020-05-04
04061644048922Reicodent02-27092020-05-04
04061644048939Reicodent02-2746-12020-05-04
04061644048946Reicodent02-2746-22020-05-04
04061644048953Reicodent02-2746-32020-05-04
04061644048960Reicodent02-2746-42020-05-04
04061644048977Reicodent02-2746-52020-05-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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M7403030030Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030031Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030032Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030033Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030034Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030035Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030036Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030059Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030060Discectomy SetSPINEOLOGY INC.LXH2026-05-28
00810166522816Expanding InnovationsEXPANDING INNOVATIONS, INC.LXH2026-05-27
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00810166522854Expanding InnovationsEXPANDING INNOVATIONS, INC.LXH2026-05-27
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