FDA.reportPublic FDA data

Inion® Universal instruments

Primary DI
06438408000348
Brand
Inion® Universal instruments
Company
Inion Oy
Model
1
Catalog number
ACC-9802
Device description
Inion Thermo Drape
Published
2020-05-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
false

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
06438408000355PrimaryGS10
M224ACC980211SecondaryHIBCC0
06438408000348Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438408000355064384080003556438408000355
06438408000348064384080003486438408000348

GMDN Terms#

Term, Definition table
TermDefinition
Fixation-implant water bath drapeA sterile, flexible covering made of a synthetic material (e.g., plastic) that is intended to be wrapped around surgical fixation implants such as plates or screws, usually bioabsorbable, while they are submerged in a heated water bath to make them more malleable. It encapsulates the implants in order to maintain their sterility while being bathed. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
367994657
Device count
5
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
true
Expiration date on label
false
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
06438408012099Inion CPS™ instrumentation1INS-92752026-01-21
06438408012105Inion CPS™ instrumentation1INS-92762026-01-21
06438408012112Inion CPS™ instrumentation1INS-92772026-01-21
06438408012129Inion CPS™ instrumentation1INS-92782026-01-21
06438408012136Inion CPS™ instrumentation1INS-92792026-01-21
M224INS900510Inion instrument1INS-90052016-08-31
M224INS90059Inion instrument0INS-90052016-08-31
M224INS901310Inion instrument1INS-90132016-08-31
M224INS90139Inion instrument0INS-90132016-08-31
M224INS902810Inion instrument1INS-90282016-08-31
M224INS90289Inion instrument0INS-90282016-08-31
M224INS90359Inion instrument0INS-90352016-08-31
M224INS90369Inion instrument0INS-90362016-08-31
M224INS90379Inion instrument0INS-90372016-08-31
M224INS907110Inion instrument1INS-90712016-08-31
M224INS90719Inion instrument0INS-90712016-08-31
M224INS909710Inion instrument1INS-90972016-08-31
M224INS90979Inion instrument0INS-90972016-08-31
06438408007958Inion BioRestore™1BRS-54322019-08-09
06438408007972Inion BioRestore™1BRS-54352019-08-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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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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