FDA.reportPublic FDA data

Surgical Cap (tie back) Non-sterile (35g SMS)

Primary DI
20376885033018
Brand
Surgical Cap (tie back) Non-sterile (35g SMS)
Company
Emergency Medical Solutions LLC
Model
EMS-09251
Device description
Surgical Cap (tie back) Non-sterile (35g SMS) blue and white [EMS-09251]
Published
2021-05-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
FYFCap, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FYFCap, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20376885033018PrimaryGS10
00376885033014Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2037688503301820376885033018
00376885033014003768850330143768850330140376885033014

GMDN Terms#

Term, Definition table
TermDefinition
Surgical cap, single-useA non-sterile 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 is usually made of reinforced paper or non-woven materials. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117478411
Device count
1000
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
2037688502601040gsm PP Bouffant Cap EMS-081312021-05-12
2037688502701735gsm sms Bouffant CapEMS-082412021-05-12
2037688502901120gsm PP Bouffant CapEMS-081212021-05-12
20376885031014Surgical Cap (tie back) Non-sterile (35gsm SMS) EMS-092112021-05-12
20376885032011Surgical Cap (tie back) Non-sterile (30g SMS) EMS-091412021-05-12
20376885034015Surgical Cap (tie back) Non-sterile (30g PP)EMS-091212021-05-12
20376885035012Beard Cover (20gsm PP) [EMS-12111]EMS-121112021-05-12
20376885036019Head and Beard Cover Combined Cover (20gsm PP) [EMS-13111]EMS-131112021-05-12
30376885028011Nurse Cap 35gsm SMSEMS-082512021-05-12
3037688503001416gsm PP Bouffant CapEMS-081112021-05-12
20376885018015 Knee high boot covers (45g SMS)EMS-11211B2021-05-12
20376885019012 Knee high boot covers (45g SMS)EMS-112222021-05-12
20376885020018 Knee high boot covers (45g SMS)EMS-112112021-05-12
20376885021015Knee high boot cover (40g SMS)EMS-113112021-05-12
20376885022012Knee high Isolation boot cover (65gsm pp+pe + peva non slip strips) [EMS-11411]EMS-114112021-05-12
20376885023019Shoe cover (35gsm PP half elastic) [EMS-10221]EMS-102212021-05-12
20376885024016Shoe cover (33gsm PP full elastic) [EMS-10211]EMS-102112021-05-12
20376885025013Shoe cover (40gsm PP half elastic) [EMS-10232]EMS-102322021-05-12

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00199536901186BluelineTransparent Supply Solutions Ltd.FYF2026-05-15
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20197344202215MEDLINEMEDLINE INDUSTRIES, INC.FYF2026-03-16
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