Home GUDID 00192896109230 Lead Hand Pediatric
Primary DI 00192896109230
Brand Lead Hand Pediatric
Company SONTEC INSTRUMENTS, INC.
Model 48-0339
Device description Lead Hand Pediatric
Published 2021-05-06
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name FMQ Restraint, protective
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FMQ Restraint, Protective General Hospital 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00192896109230 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00192896109230 00192896109230 192896109230 0192896109230
GMDN Terms# Term, Definition table Term Definition Limb/torso/head restraint, reusable A non-rigid device, typically a strap(s) or band(s) or garment-like, intended to be temporarily placed on or around one or more parts of a patient’s body (e.g., torso, limbs, head) to restrict movement, to facilitate patient positioning and stabilization during a medical procedure, and/or to prevent injury/hazards while potentially permitting limited movement. It is made of various materials (e.g., fabric, nylon, leather, or foam) and typically anchored to a fixture or furniture part (e.g., a bedrail, operating table). It is not intended for immobilization of specific joint. This is a reusable device.
Device Sizes# Type, Value, Unit table Type Value Unit Length 9.75 Inch
Sterilization Methods# Method table Method "[""Moist Heat or Steam Sterilization"", ""Dry Heat Sterilization""]" Moist Heat or Steam Sterilization;Dry Heat Sterilization
Regulatory Flags# DUNS number 040729840 Device count 1 Premarket exempt true Lot or batch true No natural rubber latex true Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10888277198739 MEDLINE MEDLINE INDUSTRIES, INC. FMQ 2026-09-18 00810101280696 sparrow swaddle™ - term infant size LITTLE SPARROWS TECHNOLOGIES LLC FMQ 2026-07-27 00810101280702 feather swaddle™ LITTLE SPARROWS TECHNOLOGIES LLC FMQ 2026-07-27 00810101280719 sparrow swaddle™ - preemie infant size LITTLE SPARROWS TECHNOLOGIES LLC FMQ 2026-07-27 10080196310128 MEDLINE MEDLINE INDUSTRIES, INC. FMQ 2025-06-03 00195278925428 Pristina Paddle GE MEDICAL SYSTEMS FMQ 2025-01-09 09010279001708 iFIX iSYS Medizintechnik GmbH FMQ 2024-07-30 09010279001715 iFIX iSYS Medizintechnik GmbH FMQ 2024-07-30 10080196281374 Medline MEDLINE INDUSTRIES, INC. FMQ 2024-05-01 10190676003232 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-06 10190676003348 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-06 10190676003355 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-06 10190676005441 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-06 10190676005458 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-06 10190676005465 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-06 10190676001016 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-05 10190676001085 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-05 10190676001108 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-05 10190676002518 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-05 10190676002525 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-05 10190676002532 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-05 10190676002549 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-05 10190676002556 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-05 10190676002563 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-05 10190676002570 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-05 10190676002594 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-05 10190676002600 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-05 10190676002617 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-05 10190676002624 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-05 10190676002631 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-05
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