Locking Syringe

Primary DI
10813079020018
Brand
Locking Syringe
Company
REMINGTON MEDICAL, INC.
Model
LSS-100
Catalog number
LSS-100
Device description
10cc
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNWINSTRUMENT, BIOPSY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNWInstrument, BiopsyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K943651000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K943651000TECHNA-CUT ASPIRATION NEEDLEManan Medical Products, Inc.1994-09-29KNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10813079020018PackageGS125In Commercial Distribution
20813079020015PackageGS110In Commercial Distribution
00813079020011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081307902001810813079020018
2081307902001520813079020015
00813079020011008130790200118130790200110813079020011

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume10Milliliter

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(800)989-0057Quality@Remmed.com

Regulatory Flags#

DUNS number
788472314
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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Primary DI, Brand, Company table
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