FDA.report

X-RAY FOOT/LEG SECTION

Primary DI
10841736112950
Brand
X-RAY FOOT/LEG SECTION
Company
SKYTRON LLC
Model
5-010-02-4B
Device description
3/8" X-RAY FT/LEG SECTION WITH CUT OUT
Published
2019-10-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
10841736112950PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1084173611295010841736112950

GMDN Terms

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

Contacts

PhoneEmail
800-759-8766info@skytron.us

Regulatory Flags

DUNS number
078375583
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
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

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10841736124427Sterling 1000-MIS-WA1000-MIS-WA2025-12-09
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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
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10841736124946Skytron4-030-10-2WS4-030-10-2WS2025-12-03

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