FDA.reportPublic FDA data

Table Pads

Primary DI
00628341930246
Brand
Table Pads
Company
CDR Systems Inc
Model
1
Catalog number
TP
Device description
Table Pad
Published
2019-12-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYEAccelerator, Linear, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122888000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122888000CDR SYSTEMS PRECISION PATIENT POSITIONING SYSTEMCdr Systems, Inc.2013-04-30IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10628341930243PackageGS11In Commercial Distribution
00628341930246PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1062834193024310628341930243
00628341930246006283419302466283419302460628341930246

GMDN Terms#

Term, Definition table
TermDefinition
Operating table patient pressure distribution pad, reusableA cushion (e.g., gel-filled, foam) intended to be placed between an operating table mattress or a patient positioner (e.g., torso intraoperative positioner, perineal post) and the patient to distribute the patient's body weight over a large surface area, for the prevention of pressure sores and tissue necrosis on prominent parts of the patient's body when immobilized for extended periods during surgery. It is available in various dimensions and shapes to accommodate various body parts such as the buttocks, shoulders, heels, or the entire body (usually excluding the head). This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
403-850-7035info@cdrsys.ca

Regulatory Flags#

DUNS number
206950904
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628341931915Instaform1IF-012026-08-17
00628341930512Extremity Lock1EXT-24STD2024-12-11
00628341930529Extremity Lock1EXT-24STD-K2025-01-21
00628341930352Freedom1PLUS2019-12-31
00628341930369Freedom1PLUS-K2019-12-31
00628341930413Solid Bolus1S-Bolus2025-01-21
10628341930410Solid Bolus1S-Bolus2025-01-21
10628341930526Extremity Lock1EB-24STD-K2025-01-21
10628341930519Extremity Lock1EB-24STD2024-12-11
00628341930505EQUILIBRIUM12024-01-25
10628341930502EQUILIBRIUM12024-01-25
00628341930376Thermoplastic12023-12-31
00628341930383Thermoplastic12023-12-31
10628341930373Thermoplastic12023-12-31
10628341930380Thermoplastic12023-12-31
00628341930482Freedom1AP22023-08-08
00628341930499Freedom1AP2-K2023-08-08
00628341930468TBI1TBI202023-03-08
10628341930465TBI1TBI202023-03-08
00628341930444Freedom1LBST2023-02-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850016008176VeraFormViscus Biologics LLCIYE2024-01-16
07340145700421Gold AnchorNaslund Medical ABIYE2023-01-23
07340145700445Gold AnchorNaslund Medical ABIYE2023-01-23
07340145700506Gold AnchorNaslund Medical ABIYE2023-01-23
07340145700582Gold AnchorNaslund Medical ABIYE2023-01-23
07340145700643Gold AnchorNaslund Medical ABIYE2023-01-23
07340145700667Gold AnchorNaslund Medical ABIYE2023-01-23
07340145701060Gold AnchorNaslund Medical ABIYE2023-01-23
07340145701084Gold AnchorNaslund Medical ABIYE2023-01-23
07340145701107Gold AnchorNaslund Medical ABIYE2023-01-23
07340145701121Gold AnchorNaslund Medical ABIYE2023-01-23
07340145701145Gold AnchorNaslund Medical ABIYE2023-01-23
07340145701169Gold AnchorNaslund Medical ABIYE2023-01-23
07340145701183Gold AnchorNaslund Medical ABIYE2023-01-23
07340145701206Gold AnchorNaslund Medical ABIYE2023-01-23
07340145701220Gold AnchorNaslund Medical ABIYE2023-01-23
B887001062X-MARK UltraIzi Medical Products, LLCIYE2022-07-18
B887001067X-MARK UltraIzi Medical Products, LLCIYE2022-07-18
B8870010010X-MARKIzi Medical Products, LLCIYE2022-06-17
B8870010020X-MARKIzi Medical Products, LLCIYE2022-06-17
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B8870010070X-MARKIzi Medical Products, LLCIYE2022-06-17
B8870010080X-MARKIzi Medical Products, LLCIYE2022-06-17
B8870010090X-MARKIzi Medical Products, LLCIYE2022-06-17
B8870010210X-MARKIzi Medical Products, LLCIYE2022-06-17
B8870010220X-MARKIzi Medical Products, LLCIYE2022-06-17
B8870010230X-MARKIzi Medical Products, LLCIYE2022-06-17