FDA.report

RTMED

Primary DI
06971642800515
Brand
RTMED
Company
Shandong Haidike Medical Products Co., Ltd.
Model
Flat cap, round cap
Published
2022-12-07
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
true

Related Records

Product Codes

CodeName
FYFCap, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
FYFCap, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06971642800515PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06971642800515069716428005156971642800515

GMDN Terms

TermDefinition
Surgical cap, single-useA head covering designed as a cap intended to be worn by surgical staff during an operation to protect both the patient and themselves from the transfer of microorganisms, body fluids, and particulate material; it may also be used as a hygienic head covering in other healthcare settings. It is usually made of reinforced paper or non-woven materials. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
550402542
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
06971642801390RTMED2/0 75cm Reverse Cutting 3/8 26mm2024-02-22
06971642801413RTMED2/0 75cm Cutting 3/8 30mm2024-02-22
06971642804285RTMED2 Without Needle 150cm2024-02-22
06971642804292RTMED6/0 Without Needle 150cm2024-02-22
06971642804308RTMED5/0 75cm Cutting 3/8 16mm2024-02-22
06971642804315RTMED5/0 75cm Round Bodied 1/2 13mm2024-02-22
06971642804322RTMED5/0 Without Needle 150cm2024-02-22
06971642804346RTMED4/0 75cm Reverse Cutting 3/8 19mm2024-02-22
06971642804353RTMED4/0 75cm Round Bodied 1/2 16mm2024-02-22
06971642804360RTMED4/0 Without Needle 150cm2024-02-22
06971642804377RTMED3/0 75cm Reverse Cutting 3/8 19mm2024-02-22
06971642804384RTMED3/0 75cm Cutting 3/8 24mm2024-02-22
06971642804391RTMED3/0 75cm Reverse Cutting 3/8 26mm2024-02-22
06971642804407RTMED3/0 75cm Cutting 3/8 30mm2024-02-22
06971642804414RTMED3/0 75cm Round Bodied 1/2 30mm2024-02-22
06971642804421RTMED3/0 Without Needle 150cm2024-02-22
06971642801420RTMED2/0 75cm Round Bodied 1/2 24mm2024-02-23
06971642801437RTMED2/0 75cm Round Bodied 1/2 35mm2024-02-23
06971642801444RTMED2/0 Without Needle 150cm2024-02-23
06971642801451RTMED0 75cm Reverse Cutting 3/8 37mm2024-02-23

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