FDA.report

Palmero Healthcare, LLC

Primary DI
00840415101417
Brand
Palmero Healthcare, LLC
Company
Palmero Healthcare LLC
Model
101B
Catalog number
101B
Device description
MOUTH PROPS -ADULT ADULT
Published
2021-02-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
BRWProtector, dental

Product Code Classifications

CodeDeviceSpecialtyClass
BRWProtector, DentalAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840415101417PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840415101417008404151014178404151014170840415101417

GMDN Terms

TermDefinition
Mouth gag, non-adjustableA mechanical device without adjustable parts intended to be placed between the teeth of the upper and lower jaws of a patient to maintain an open oral cavity, typically during emergent placement of an artificial airway or for an oral surgical intervention. It is designed to be inserted between the teeth to force the jaws apart and may be in the form of a wedge block, wedge screw, or sprung wedge. Depending on the design it may also be referred to as a jaw spreader, oral wood screw, or mouth prop. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(203)377-6424scott@jjinstruments.com

Regulatory Flags

DUNS number
080530675
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
true
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00840415113083Palmero Healthcare20NAVY20NAVY2023-05-08
00840415113090Palmero Healthcare20GOLD20GOLD2023-05-08
00840415113106Palmero Healthcare20RED20RED2023-05-08
00840415113113Palmero Healthcare20MNAVY20MNAVY2023-05-08
00840415113120Palmero Healthcare20MGOLD20MGOLD2023-05-08
00840415113137Palmero Healthcare20MRED20MRED2023-05-08
00840415113144Palmero Healthcare20UNAVY20UNAVY2023-05-08
00840415113151Palmero Healthcare20UGOLD20UGOLD2023-05-08
00840415113168Palmero Healthcare20URED20URED2023-05-08
00840415113175Palmero Healthcare34NAVY34NAVY2023-05-08
00840415113182Palmero Healthcare34GOLD34GOLD2023-05-08
00840415113199Palmero Healthcare34RED34RED2023-05-08
00840415113205Palmero Healthcare34MNAVY34MNAVY2023-05-08
00840415113212Palmero Healthcare34MGOLD34MGOLD2023-05-08
00840415113229Palmero Healthcare34MRED34MRED2023-05-08
00840415113236Palmero Healthcare34UNAVY34UNAVY2023-05-08
00840415113243Palmero Healthcare34UGOLD34UGOLD2023-05-08
00840415113250Palmero Healthcare34URED34URED2023-05-08
00840415113267Palmero Healthcare23BLACK23BLACK2023-05-08
00840415113274Palmero Healthcare23FORESTGREEN23FORESTGREEN2023-05-08

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