FDA.reportPublic FDA data

CF-BACKREST 60502

Primary DI
06438435605028
Brand
CF-BACKREST 60502
Company
Merivaara Oy
Model
CF-BACKREST 60502
Catalog number
100060502
Device description
Operating table accessory
Published
2023-06-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FWZOperating Room Accessories Table Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FWZOperating Room Accessories Table TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06438435605028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438435605028064384356050286438435605028

GMDN Terms#

Term, Definition table
TermDefinition
Universal operating table topA component of a modular operating table designed as a detachable table top that can be adjusted to support a patient during many types of surgical interventions. It may consists of many articulated sections that can be elevated or lowered for contouring to accommodate numerous anatomical positions (e.g., the whole table top may be adjusted to form a curved surface), or intended to be used in conjunction with dedicated accessories (i.e., positioners, traction devices) to satisfy the requirements of many clinical specialties; it may have x-ray transparent features.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+35833394611merivaara@merivaara.com

Regulatory Flags#

DUNS number
368647421
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
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
06438435118023MULTITASK ARM BOARDMULTITASK ARM BOARD1000118022023-11-03
06438435125854 TOTAL KNEE STABILIZER MV-12585 TOTAL KNEE STABILIZER MV-12585 1000125852023-11-03
06438435001073WRIST STRAP PAIR 107WRIST STRAP PAIR 1071000001072023-06-26
06438435001103STRAP PAIR 110STRAP PAIR 1101000001102023-06-26
06438435001202SIDE SUPPORT 120SIDE SUPPORT 1201000001202023-06-26
06438435001257ARM REST 125ARM REST 1251000001252023-06-26
0643843500138790° KNEE SUPPORT 13890° KNEE SUPPORT 1381000001382023-06-26
06438435001516ARM RESTS 151ARM RESTS 1511000001512023-06-26
06438435015018BOWL 6 L W/O DRAINAGE 201501BOWL 6 L W/O DRAINAGE 2015011002015012023-06-26
06438435015025BOWL 6 L WITH DRAINAGE 201502BOWL 6 L WITH DRAINAGE 2015021002015022023-06-26
06438435015711BOWL 6 L W/O DRAINAGE 201571BOWL 6 L W/O DRAINAGE 2015711002015712023-06-26
06438435015728BOWL 6 L WITH DRAINAGE 201572BOWL 6 L WITH DRAINAGE 2015721002015722023-06-26
06438435116517ROUND LATERAL BRACE MV-11651ROUND LATERAL BRACE MV-116511000116512023-06-26
06438435116524RECTANGULAR LATERAL BRACE MV-11652RECTANGULAR LATERAL BRACE MV-116521000116522023-06-26
06438435180013LIGHT FOOT REST 18001LIGHT FOOT REST 180011000180012023-06-26
06438435181591SCREEN 18159 FOR 6 L BOWLSSCREEN 18159 FOR 6 L BOWLS1000181592023-06-26
06438435181836WIRE BASKET 18183WIRE BASKET 181831000181832023-06-26
06438435181898OXYGEN BOTTLE HOLDER 18189OXYGEN BOTTLE HOLDER 181891000181892023-06-26
06438435191125FEMORAL COUNTER TRACTION POST 19112FEMORAL COUNTER TRACTION POST 191121000191122023-06-26
06438435191149STIRRUP CLAMP WITH ROTATION 19114STIRRUP CLAMP WITH ROTATION 191141000191142023-06-26

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