FDA.reportPublic FDA data

OPERON

Primary DI
07613327395082
Brand
OPERON
Company
STRYKER COMMUNICATIONS INC.
Model
OZ 7552275
Catalog number
OZ 7552275
Device description
Surgical Table Pad, 3 Inch Shoulder Chair, Right
Published
2019-01-24
Public version status
Update
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
LWGSURGICAL TABLE CUSHION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LWGSurgical Table CushionGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327395082PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327395082076133273950827613327395082

GMDN Terms#

Term, Definition table
TermDefinition
Operating table mattress, basicA foam-filled cushion designed as a component of an operating table to serve as the surface upon which the patient is placed. It is typically filled with high-density polyurethane or a memory foam, and may be an integral part of the table (i.e., removable only with tools) or loosely fitted to the table top (e.g., by way of press studs, Velcro strips, or eyeholes and pegs) and is removable for cleaning. The device is firm, waterproof, and washable using strong disinfectants. It is available as one full-length piece or in sections. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
+1(866)726-3705SCC-CS2@stryker.com

Regulatory Flags#

DUNS number
078807493
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327394931OPERONOZ 7552475OZ 75524752019-01-24
07613327395037OPERONOZ 7552075OZ 75520752019-01-24
07613327661194In-Light CameraP59109P591092025-08-27
07613327054507FLEXIS068240050006824005002023-06-07
07613327061178Visum BladeP22310P223102016-09-23
07613327054286NA068200028006820002802020-07-29
07613327054293NA068200028106820002812020-07-29
07613327166712NA068200085206820008522020-07-29
07613327166736NA068200085006820008502020-07-29
07613327589344OPERONOZ 7580275OZ 75802752022-03-22
07613327395068OPERONOZ 7561075OZ 75610752019-01-24
07613327395099OPERONOZ 7569075OZ 75690752019-01-24
07613327395136OPERONOZ 7568875OZ 75688752019-01-24
07613327054330Visum068200125206820012522016-09-23
07613327054347Visum068200125306820012532016-09-23
07613327054415Visum068240013706824001372016-09-23
07613327054422Visum068240013806824001382016-09-23
07613327061185Visum Blade, iSuiteP22309P223092016-09-30
07613327384505OPERONOZ 7559275OZ 75592752019-01-24
07613327384512OPERONOZ 7559375OZ 75593752019-01-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00857915007811Table PadA.M. SURGICAL, INC.LWG2026-06-10
10857915007818Table Pads (5-pack)A.M. SURGICAL, INC.LWG2026-06-10
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10810087350908CoulmedCoulmed Products Group LLCLWG2023-01-06
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10810087350939CoulmedCoulmed Products Group LLCLWG2023-01-06
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10810087352001CoulmedCoulmed Products Group LLCLWG2023-01-06
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