FDA.reportPublic FDA data

Reicodent

Primary DI
04061644045600
Brand
Reicodent
Company
devemed GmbH
Model
02-1020-2
Device description
Gauze Packer "Luniatschek" # 2 2,5 mm Octagonal 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
OTC
false
Sterile
false
Single use
false

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
04061644045600PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04061644045600040616440456004061644045600

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
04061644035953Reicodent02-876-12 C2020-04-15
04061644036851Reicodent02-878-12 C2020-04-15
04061644065349Reicodent02-1086-41 C2020-12-29
04061644065356Reicodent02-1086-10 C2020-12-29
04061644065363Reicodent02-1086-11 C2020-12-29
04061644065370Reicodent02-1086-30 C2020-12-29
04061644065387Reicodent02-1086-31 C2020-12-29
04061644065394Reicodent02-1086-60 C2020-12-29
04061644065400Reicodent02-1086-61 C2020-12-29
04061644004058devemed720-1002020-04-21
04061644004072devemed725-32020-04-21
04061644004089devemed725-42020-04-21
04061644004355devemed790-12020-04-21
04061644004362devemed790-22020-04-21
04061644004379devemed790-32020-04-21
04061644004454devemed794-602020-04-21
04061644004461devemed794-612020-04-21
04061644004478devemed794-622020-04-21
04061644007646devemed794-3412020-04-21
04061644008667devemed793-AS-12020-04-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00198506091025ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091032ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091049ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091056ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091063ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091070ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091087ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
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