FDA.report

Skytron

Primary DI
10841736122829
Brand
Skytron
Company
SKYTRON LLC
Model
5-010-18-B
Catalog number
5-010-18-B
Device description
3/8 Inch X-RAY TOP SET 6600
Published
2022-01-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FQOTABLE, OPERATING-ROOM, AC-POWERED

Product Code Classifications

CodeDeviceSpecialtyClass
FQOTable, Operating-Room, Ac-PoweredGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10841736122829PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1084173612282910841736122829

GMDN Terms

TermDefinition
Fluoroscopy/angiography table topA component of a modular operating table designed as a detachable table top constructed for use during surgical procedures requiring fluoroscopic guidance, such as cardiovascular surgery and other interventional radiology procedures (e.g., biopsy). This table top is typically a one-piece, and completely flat construction with an x-ray translucent section(s) providing x-rays free of artefacts. It is not dedicated to breast biopsy, and not designed to position a patient during other specialist surgeries (i.e., it is not a specialist operating table top with x-ray transparent features).

Storage And Handling

TypeLowHighCondition
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius70 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800) 759-8766info@skytron.us

Regulatory Flags

DUNS number
078375583
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
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

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10841736124410Skytron 200 x 400 VESA Adapter Plate4A-VESA-200-400 Freedom4A-VESA-200-4002026-03-19
10841736125141CleanStartCSTART-7115CSTART-71152025-12-19
10841736125158CleanStartCSTART-7130CSTART-71302025-12-19
10841736125165CleanStartCSTART-8115CSTART-81152025-12-19
10841736125172CleanStartCSTART-8130CSTART-81302025-12-19
10841736125189CleanStartCSTART-8315CSTART-83152025-12-19
10841736125196CleanStartCSTART-8330CSTART-83302025-12-19
10841736125202CleanStartCSTART-9815CSTART-98152025-12-19
10841736125219CleanStartCSTART-9830CSTART-98302025-12-19
10841736124298Skytron LLC40-LC-ED40-LC-ED2025-12-09
10841736124427Sterling 1000-MIS-WA1000-MIS-WA2025-12-09
10841736124434Sterling 1800-MIS-WA1800-MIS-WA2025-12-09
10841736124861Skytron4-030-42-94-030-42-92025-12-03
10841736124878Skytron1-012-04-21-012-04-22025-12-03
10841736124885Skytron1-012-04-31-012-04-32025-12-03
10841736124892Skytron1-012-04-41-012-04-42025-12-03
10841736124908Skytron1-012-04-51-012-04-52025-12-03
10841736124915Skytron2-060-05-3S2-060-05-3S2025-12-03
10841736124939Skytron4-030-01-14-030-01-12025-12-03
10841736124946Skytron4-030-10-2WS4-030-10-2WS2025-12-03

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10841736124410Skytron 200 x 400 VESA Adapter PlateSKYTRON LLCFQO2026-03-19
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00190376678764ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00190376678771ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00190376678795ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00190376678801ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00190376678818ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00190376678825ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00190376678832ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
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10841736124861SkytronSKYTRON LLCFQO2025-12-03
10841736125226SkytronSKYTRON LLCFQO2025-12-03
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