FDA.reportPublic FDA data

Protective Pediatric Mitts

Primary DI
00027479280122
Brand
Protective Pediatric Mitts
Company
MEDI-TECH INTERNATIONAL CORPORATION
Model
MTPM391M
Catalog number
MTPM391M
Device description
Protective Pediatric Mitts - Size Toddler (1-3 Years) - Pair
Published
2019-07-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMQRestraint, Protective

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMQRestraint, ProtectiveGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110377000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110377000PROTECTIVE RESTRAINTMedi-Tech Intl. Corp.2011-04-25FMQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00027479280122PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00027479280122000274792801220274792801220027479280122

GMDN Terms#

Term, Definition table
TermDefinition
Limb/torso/head restraint, reusableA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
414-570-8880Marilyn.Geiger@medi-techintl.com

Regulatory Flags#

DUNS number
063865158
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00027479153259SpandaNetteMTSNP15325MTSNP153252019-10-29
00027479132254SpandaNette MTSN13225MTSN132252019-10-29
00027479134258SpandaNetteMTSN13425MTSN134252019-10-29
00027479135255SpandaNette MTSN13525MTSN135252019-10-29
00027479131059SpandaNetteMTSN131025MTSN1310252019-10-29
00027479131257SpandaNetteMTSN31225MTSN312252019-10-29
00027479131455SpandaNetteMTSN131425MTSN1314252019-10-29
00027479133251SpandaNette MTSN13325MTSN133252019-10-29
00027479136252SpandaNette MTSN13625MTSN136252019-10-29
00027479138256SpandaNetteMTSN13825MTSN138252019-10-29
00027479152252SpandaNetteMTSNP15225MTSNP152252019-10-29
00027479142505SpandaNette MTSNB14250MTSNB142502019-09-11
00027479143502SpandaNette MTSNB14350MTSNB143502019-09-11
00027479144509SpandaNette MTSNB14450MTSNB144502019-09-11
00027479145506SpandaNette MTSNB14550MTSNB145502019-09-11
00027479146503SpandaNetteMTSNB14650MTSNB146502019-09-11
00027479148507SpandaNetteMTSNB14850MTSNB148502019-09-11
00027479151057SpandaNetteMTSNP151025MTSNP1510252019-09-11
00027479151255SpandaNetteMTSNP151225MTSNP1512252019-09-11
00027479151453SpandaNette MTSNP151425MTSNP1514252019-09-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10080196310128MEDLINEMEDLINE INDUSTRIES, INC.FMQ2025-06-03
10748426141125Medline-MicrotekMicrotek Medical LLCFMQ2025-04-08
09010279001708iFIXiSYS Medizintechnik GmbHFMQ2024-07-30
09010279001715iFIXiSYS Medizintechnik GmbHFMQ2024-07-30
10080196281374MedlineMEDLINE INDUSTRIES, INC.FMQ2024-05-01
M1435040070Protective Vest No SleeveKenad SG Medical, Inc.FMQ2023-09-17
10810087352766CoulmedCoulmed Products Group LLCFMQ2023-01-06
10810087353022CoulmedCoulmed Products Group LLCFMQ2023-01-06
10810087353039CoulmedCoulmed Products Group LLCFMQ2023-01-06
10810087353046CoulmedCoulmed Products Group LLCFMQ2023-01-06
10810087353053CoulmedCoulmed Products Group LLCFMQ2023-01-06
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10190676002518POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002525POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002532POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002549POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002556POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002563POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002570POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002594POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002600POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05
10190676002617POSEYPOSEY PRODUCTS, LLCFMQ2022-10-05